Central containment goals are based on the need to give the operator optimum protection based on the product’s containment band, maintaining good cGMP conditions, eliminating cross contamination, and reducing clean up requirements.

The DEC Isotube product transfer system is a low cost option for the safe loading and charging of drums of highly active pharmaceutical ingredients.

Equally effective when loading a process vessel or other charging application such as the Powder Transfer System, the DEC Isotube provides a high level of containment together with control over environmental conditions within the isolation system.

The system comprises a single vessel charging glove box, which can be connected directly to the vessel or application to be charged with powder from a drum or keg of any size. The DEC Isotube is equipped with a drum bag in/ bag out system (using endless liner technology) to ensure contained loading both in and out of the isolator.

A scale in the drum access chamber makes the system equally ideal for dispensing.

The ‘DEC Isotube’ provides a high level of containment together with control over environmental conditions. This ‘Clean Air Transfer System’ is equipped with a drum sealing system ensuring contained drum loading and powder charging.

We are able to offer a number of drum sealing options for a wide range of drum diameters.

The DEC Isodrop is ideal for product discharge from R&D to full size production units and can be used simultaneously as a complete dispensing system. Thanks to its high containment level, it is the perfect solution for sterile and highly toxic products or both. Based on 3D solid model designs, these ergonomically assessed systems are critical when dealing with the removal of toxic or sterile products from filter dryers or similar devices.

The isolator is equipped with automated control of the working environment and is supplied with HEPA filtration (EU14) or ULPA filtration for sterile systems. They can be configured in either disposable flexible units or solid systems. Dependent of the size of the system and the filter dryer valve configuration both glove port and half suit systems are available. The operator’s access into the isolator can be through simple two glove port arrangements up to multiple glove port processes with integrated pack-off into drums or liners or through half suit installations to cope with the large plug valves found on the older filter dryer systems.

The DEC Isodrop can be linked to a variety of DEC Systems for contained product sampling, transfer and pack-off processes with weighing options.

Features

High level of containment <20 ng/m³

Quick assembly and simple operation

Safe for operator and environment

Works under inerted atmosphere for handling low MIE powder

Fully CIP and SIP with integrated VHP® system for a high sterility assurance level

Process integration to GAMP5 and complete CFR 21 Part 11 compliance available

‘Open Manway Charging’ is no longer acceptable, but a new development being successfully used by Dec clients worldwide, is the ‘DEC Isocharge’. Combining the open aspects of a Laminar Flow Booth with a Glovebox Isolator to enable the ‘Rapid and Safe Charging’ of powder products.

Fast operation for multiple bag emptying

Safe handling of toxic, sticky or lumpy powders

High containment (<1μg/m3)

Stand-alone unit

Cost effective

Mobile

One unit can be used to charge multiple receiving vessels

The revolutionary DEC Isocharge is a low cost method of both dispensing and charging bags into reactors or receiving systems via the PTS Powder Transfer System*. The DEC Isocharge combines the advantages of isolation and laminar flow technology, providing high containment of < 1μg/m3 per 8 h TWA.

The station’s chamber is open to the side allowing easy bag introduction. A simple door only needs to be closed during WIP to prevent splashes. All WIP fluids can be drained from the chamber via the PTS Powder Transfer System* into the reactor, which also cleans the transfer hose and the PTS.

Using the gloves the operator will move the bag of powder into position on the charging bars above the integrated hopper. The bag is then split and the powder emptied through the bars. The empty bag is disposed through the adjacent continuous liner bag-out port. The operator now starts the PTS and charges the required amount of powder to the vessel.

On the other side of the station opposite the bag entry point is an exhaust plenum. A HEPA filtered exhaust is located on top of the plenum, connected to the exhaust fan. The fan is available with a simple manual damper or can be fully automated depending on requirements.

Internal view of the ‘DEC Isocharge’ utilizing both Laminar Flow and Glovebox Technology to allow safe and rapid powder charging.
Our ‘Clean Room Manufactured and Packed’ for optimum cleanliness, Continuous Pack-Off Liner is folded ‘Top to Bottom’ to give a greatly increased capacity and high containment, <1μg/m³.
Dec’s own, purpose built, SMEPAC compliant facility for Containment Testing. A twin chamber ‘DEC Isodrop’ facilitates both the contained emptying and pack-off of product from a vessel, such as a filter dryer.
The ‘DEC Isotube’ for fully contained and clean transfer of products in drums, in combination with DEC's dense phase Powder Transfer System PTS or by gravity.

Be it for operator or product protection, the DEC Group has a solution for all your powder handling requirements.

* TWA = 8-hour Time Weighted Averages (TWA) - are an average value of exposure over the course of an 8 hour work shift.

* GMP = A good manufacturing practice (GMP) is a production and testing practice that helps to ensure a quality product. Many countries have legislated that pharmaceutical and medical device companies must follow GMP procedures, and have created their own GMP guidelines that correspond with their legislation. Basic concepts of all of these guidelines remain more or less similar to the ultimate goals of safeguarding the health of the patient as well as producing good quality medicine, medical devices or active pharmaceutical products. In the U.S. a drug may be deemed adulterated if it has passed all of the specifications tests but is found to be manufactured in a condition which violates current good manufacturing guideline. Therefore, complying with GMP is a mandatory aspect in pharmaceutical manufacturing.

* cGMP = Cyclic guanosine monophosphate (cGMP) is a cyclic nucleotide derived from guanosine triphosphate (GTP). cGMP acts as a second messenger much like cyclic AMP. Its most likely mechanism of action is activation of intracellular protein kinases in response to the binding of membrane-impermeable peptide hormones to the external cell surface.